Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics

This study has been completed.
Sponsor:
Collaborator:
Phytopharm Consulting Brazil
Information provided by (Responsible Party):
Laboratorio Saude Ltda.
ClinicalTrials.gov Identifier:
NCT01485328
First received: December 16, 2008
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.


Condition Intervention Phase
Digestive System Disorders
Drug: AMARGOL®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics

Resource links provided by NLM:


Further study details as provided by Laboratorio Saude Ltda.:

Primary Outcome Measures:
  • VAS - visual analogue scale [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal


Enrollment: 60
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMARGOL
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture
Placebo Comparator: Vehicle without active principles
per oral solution 40 mL single dose
Drug: AMARGOL®
per oral solution, 40 mL single dose
Other Names:
  • AMARGOL
  • Phytomedicine
  • Herbal Extracts Mixture

Detailed Description:

This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.

AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.

Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.

Placebo controlled test

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years old
  • 65-85 Kg
  • healthy volunteers

Exclusion Criteria:

  • chronic dyspeptics illness chronic congestive cardiac problems
  • pulmonary problems
  • diabetes, thyroid problems
  • pregnancy
  • bowel syndrome
  • hemorrhoids
  • colitis
  • allergies for any formula components.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485328

Locations
Brazil
Phytopharm Consulting
Porto Alegre, RS, Brazil, 90130-021
Sponsors and Collaborators
Laboratorio Saude Ltda.
Phytopharm Consulting Brazil
Investigators
Principal Investigator: Angelo G Chaves, Doctor
  More Information

No publications provided

Responsible Party: Laboratorio Saude Ltda.
ClinicalTrials.gov Identifier: NCT01485328     History of Changes
Other Study ID Numbers: labsaude-001-ama
Study First Received: December 16, 2008
Last Updated: December 5, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratorio Saude Ltda.:
Dyspepsia
Flatulence
Aerophagia
Constipation

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014